Recon: FDA approves Iovance’s cell therapy Amtagvi for solid tumors; Pfizer’s inflammatory bowel disease drug authorized in EU
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.In Focus: US
- In ‘major milestone,’ FDA approves first cell therapy for solid tumors (STAT) (Endpoints)
- Key congressman blasts HHS for lack of cooperation on Covid-19 (STAT)
- FDA sets June decision deadline for potential full approval, label expansion of Sarepta’s Duchenne gene therapy (STAT)
- FDA approves Roche, Novartis' Xolair to prevent severe outcomes from common food allergies (Fierce Pharma)
- U.S. FDA approves AstraZeneca's Tagrisso-chemo combo (Reuters)
- GSK and others delist Orange Book patents after FTC targets protections on inhalers and epinephrine injectors (STAT)
- Senators call on FDA to address 'deluge of misleading promotions' on social media (STAT)
- Novartis, zeroing in on innovative meds, launches strategic review of India outfit (Fierce Pharma)
- Following FDA rejection, Sanofi and Regeneron's Dupixent gains Japanese approval in hives condition (Fierce Pharma)
- EU drug regulator to review Lilly's Mounjaro in multi-dose pen (Reuters)
- Five Key Meetings Offering EU Medtech Regulatory Insights Over Next Four Months (MedTech Insight)
- Philippines FDA Slashes Approval Timelines For Generic Drugs (Pink Sheet)
- England’s NICE Unconvinced That Sanofi’s Sarclisa Is Cost Effective After Cancer Drugs Fund Review (Pink Sheet)
- Data Exclusivity Demand In EFTA-India Deal: Access, Licensing, Other Implications (Pink Sheet)
- Australia Identifies HTA Challenges Posed By Emerging Technologies (Pink Sheet)
- Pfizer inflammatory bowel disease drug wins EU approval (Reuters)
- Novo Licenses to Almirall Potential First-in-Class Antibody Candidate (BioSpace)
- Opinion: The Promise and Challenges of CRISPR-Based Treatments (BioSpace)
- The complicated connections between weight loss drugs and mental health (STAT)
- Eli Lilly, Novo Nordisk get growth stock status on weight-loss drug boost (Reuters)
- Opioid cravings were reduced by anti-obesity drug in small study (STAT)
- Flagship Pioneering startup lays off a third of staff (STAT)
- Denali reports a PhII ALS fail as RIPK1 deal with Sanofi hits another bump (STAT)
- Gilead's $4.3B liver bet; WuXi under fire; Exscientia CEO’s ouster; Late Friday cell therapy approval; and more (Endpoints)
- US study uncovers 275 million entirely new genetic variants (Reuters)
- FDA Accepts BLA for AstraZeneca, Daiichi Sankyo’s ADC for NSCLC (BioSpace)
- How Will FDA’s Pivot to Overall Survival Affect Cancer Drug Development? (BioSpace)
- Gilead Suspends Patient Enrollment for Magrolimab in Solid Tumor Trials (BioSpace)
- News We’re Watching: CDRH’s Maisel Announces Retirement, Fresenius Clearance, Philips and Smiths Recalls (MedTech Insight)
- FOIA Claims Bring Electroshock Device Dispute Back To Courts (MedTech Insight)
- Chapter 11 Bankruptcy, Not A Party You Would Want An Invitae For (MedTech Insight)
- Banning surprise medical bills is raising costs elsewhere (STAT)
- Organon's Humira biosimilar gets exclusive spot on VA formulary (Endpoints)
A story’s inclusion in Regulatory Recon does not imply endorsement by Regulatory Focus or RAPS.
